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Zusammenfassung Hintergrund Durch COVID-19 kam es weltweit, insbesondere in den ersten Wochen der Pandemie, zu einer Verschiebung und Absage elektiver Operationen in allen chirurgischen Fachdisziplinen. Eine Beschreibung der spezifischen Situation in gefäßchirurgischen Kliniken in Deutschland während dieser Periode ist bislang nicht erfolgt. Ziel der Arbeit Zweck der Befragung war die Erfassung der gefäßchirurgischen Leistungserbringung in der Zeit von März 2020 bis Dezember 2020, sowie von logistischen und infrastrukturellen Veränderungen, die sich durch die pandemische Lage ergeben hatten. Hierbei lag der Fokus der Umfrage auf der möglichst realitätsnahen Abbildung der Versorgungssituation anhand der Einschätzung der leitenden Gefäßchirurg*innen. Material und Methoden In Zusammenarbeit mit der Deutschen Gesellschaft für Gefäßchirurgie und Gefäßmedizin (DGG) wurde das leitende ärztliche Personal von gefäßchirurgischen Einrichtungen in Deutschland aufgefordert, an der Umfrage teilzunehmen. Die Beantwortung der Fragen erfolgte anonym. Ergebnisse Durch COVID-19 und korrespondierende Maßnahmen kam und kommt es zu relevanten Absagen und Verschiebungen von Operationen, Verlust an Kapazitäten und einer gesteigerten Personalbelastung. Es traten im Beobachtungszeitraum verspätete Versorgungen gefäßchirurgischer Krankheitsbilder und ein gehäuftes Auftreten schwererer klinischer Stadien verglichen mit dem entsprechenden Vorjahreszeitraum auf. Betroffen sind alle Versorgungsstufen, größtenteils dauern diese Veränderungen an. Diskussion Um der strukturellen Schwächung und den Einschränkungen in der Patientenversorgung zu begegnen, sind klinische Abläufe, Patientenaufklärung und Priorisierung zu optimieren. Neue Konzepte wie z. B. Telemedizin und engmaschigere klinische Kontrolle sind ggf. sinnvoll. Eine erforderliche Infrastruktur für Notfallmanagement (COVID) darf im Alltag nicht die Versorgungsqualität der gefäßchirurgischen Patient*innen negativ beeinflussen.

Kliniken und wissenschaftliche Fachgesellschaften verfolgen die Strategie, Studierende im Rahmen der Nachwuchsgewinnung bereits sehr fruh zur Berufswahl zu beraten. Deshalb beteiligte sich die Deutsche Gesellschaft fur Gefaschirurgie und Gefasmedizin (DGG) mit einem Workshop am Bundeskongress (BUKO) der Bundesvertretung der Medizinstudierenden in Deutschland (BVMD). Die vorliegende Erhebung wurde initiiert, um festzustellen, welche Vorstellungen Studierende im Allgemeinen uber das Fach Gefaschirurgie und das Tatigkeitsspektrum von Gefaschirurginnen und Gefaschirurgen haben. Wahrend des BUKO 2019 der BVMD wurde ein Workshop veranstaltet, der einen Impulsvortrag und praktische Nahtubungen beinhaltete. Vor Kursbeginn wurden die Teilnehmenden gebeten, einen Fragebogen zur Gefaschirurgie zu beantworten. Die Antworten wurden anonymisiert erfasst und qualitativ ausgewertet. Zwolf Studierende aus unterschiedlichen universitaren Standorten nahmen an dem Kurs teil. Sie befanden sich in den Fachsemestern 3–11 und verfugten haufig bereits uber chirurgische Vorerfahrungen (n = 8). Als herausragende Eigenschaften eines Gefaschirurgen wurden vor allem Feinmotorik (n = 6) und Geduld (n = 4) angesehen. Die Gefaschirurgie wurde aufgrund der Vielseitigkeit des Faches (n = 4) sowie der zur Ausubung notwendigen „mikrochirurgischen“ Fertigkeiten (n = 5) als attraktiv angesehen. Trotz der eingeschrankten Ubertragbarkeit der Ergebnisse dieser relativ kleinen Stichprobe lassen die Ergebnisse darauf schliesen, dass die Sichtbarkeit des Faches Gefaschirurgie eher gering ist. Im Hinblick auf die Berufswahl sollten neue Lehr- und Informationsangebote darauf abzielen, das Fach Gefaschirurgie fruhzeitig bekannt zu machen, um Vorurteile und Beruhrungsangste abzubauen.

Purpose: To report the outcomes of bypass grafting (BG) vs endovascular therapy (EVT) in patients with non-dialysis-dependent chronic kidney disease (CKD) and chronic limb-threatening ischemia (CLTI). Materials and Methods: The CRITISCH Registry is a prospective, national, interdisciplinary, multicenter registry evaluating the current practice of all available treatment options in 1200 consecutive CLTI patients. For the purposes of this analysis, only the 337 patients with non-dialysis-dependent CKD treated by either BG (n=86; median 78 years, 48 men) or EVT (n=251; median age 80 years, 135 men) were analyzed. The primary composite outcome was amputation-free survival (AFS); secondary outcomes were overall survival (OS) and amputation-free time (AFT). All outcomes were evaluated in Cox proportional hazards models; the results are reported as the hazard ratio (HR) and 95% confidence interval (CI). Results: The Cox regression analysis revealed a significantly greater hazard of amputation or death after BG (HR 1.78, 95% CI 1.05 to 3.03, p=0.028). The models for AFT and overall survival also suggested a higher hazard for BG, but the differences were not significant (AFT: HR 1.66, 95% CI 0.78 to 3.53, p=0.188; OS: HR 1.41, 95% CI 0.80 to 2.47, p=0.348). The absence of runoff vessels (HR 1.73, 95% CI 1.15 to 2.60, p=0.008) was associated with a decreased AFS. The likelihood of amputation was higher in male patients (HR 2.21, 95% CI 1.10 to 4.45, p=0.027) and was associated with a lack of runoff vessels (HR 1.95, 95% CI 0.96 to 3.95, p=0.065) and myocardial infarction (HR 3.74, 95% CI 1.23 to 11.35, p=0.020). Death was more likely in patients without runoff vessels (HR 1.76, 95% CI 1.11 to 2.80, p=0.016) and those with a higher risk score (HR 1.73, 95% CI 1.03 to 2.91, p=0.038). Conclusion: This analysis suggested that BG was associated with poorer AFS than EVT in patients with non-dialysis-dependent CKD and CLTI. Male sex, previous myocardial infarction, and the absence of runoff vessels were additionally identified as predictors of poorer outcomes.

ispartof: INTERNATIONAL ANGIOLOGY vol:41 issue:2 pages:91-104 ispartof: location:Italy status: published

COVID-19 resulted in postponement and cancellation of elective operations in all surgical disciplines worldwide, especially in the first weeks of the pandemic. The specific situation in vascular surgery clinics in Germany during this period has not yet been described.The purpose of the survey was to record the provision of vascular surgery services in the period from March 2020 to December 2020 as well as logistical and infrastructural changes that resulted from the pandemic situation. The focus of the survey was on mapping the supply situation as realistically as possible based on the assessment of the lead vascular surgeons.In cooperation with the German Society for Vascular Surgery and Vascular Medicine (DGG), the senior medical staff of all vascular centers in Germany were asked to take part in the survey. The questions were answered anonymously.COVID-19 and corresponding measures resulted in relevant cancellations and postponements of operations, a loss of capacities and an increased workload. During the observational period there was a delay in the treatment of vascular surgical diseases and an increased occurrence of severe clinical stages compared to the corresponding period of the previous year. All levels of care were and continue to be affected.In order to counteract the structural weakening and the restrictions in patient care, clinical processes, patient education and prioritization must be optimized. New concepts such as telemedicine and closer clinical control may make sense. A necessary infrastructure for emergency management (COVID) must not negatively affect the quality of care for (vascular) surgical patients in everyday life.

In Germany, staff exposed to radiation is monitored with official individual dosimeters. Commercially available real-time dosimeters (RTD) can be used as radiation protection dosimeters. They are worn over the apron and display the radiation dose being measured at the desired location at intervals of one second. These real-time radiation exposure measurements enable the surgical staff to take suitable measures to reduce the radiation during the operation. The objective of our study was to monitor the accuracy of the measurements taken from the real-time dosimeter and to determine the radiation scatter for individual members of the surgical staff.Prospective measurements of the operating team's exposure to radiation were carried out using a real-time dosimeter system in an operating room for vascular surgery equipped with a C-arm. Firstly the calibration of the RTD at the operating table was checked using a water phantom. Subsequently, measurements were taken during vascular interventions and surgery.When calibrated, the values of the individual RTD revealed internal significant deviations, thus a corrective factor was calculated for each RTD. In total 55 interventions on 53 patients were studied. The average dose for the RTD of the surgeon during endovascular aortic repair (n = 11) amounted to 9 ± 9 µSv (range 3.6 - 50 µSv) and during thoracic endovascular aortic repair (n = 6) 35 ± 49 µSv (3.8 - 190.3 µSv). In the case of percutaneous transluminal angioplasty of the pelvis and of the lower extremities (n = 20), the average dose for the RTD of the surgeon was 7 ± 7 µSv (1.2 - 35 µSv) and for the angiographies of the lower extremities (n = 12) at 2 ± 3 µSv (0.2 - 15.9 µSv). The real-time dosimetry provided data which contributed to the operating team changing their behaviour in the operating room.Since the dose values determined by the official dosimetry are generally very low, it is not possible to optimise the behaviour and thus the radiation protection using these dose values. This can be achieved with the radiation protection dosimeter and the dose reference levels can be defined in the new Radiation Protection Ordinance (StrlSchV). Instant feedback of the current dose rate at the place where the RTD is worn can lead to both the individual adjusting his or her personal behaviour and to optimisation of the individual's radiation protection. It is only possible to compare the measured data obtained with the RTD when calibration is carried out in advance.Die Überwachung von strahlenexponiertem Personal erfolgt in Deutschland mit amtlichen Personendosimetern. Kommerziell erhältliche Echtzeitdosimeter (EZD) lassen sich als Strahlenschutzdosimeter verwenden. Sie werden über der Röntgenschürze getragen und zeigen im Sekundenabstand die aktuell gemessene Ortsdosis an. Diese zeitnahe Einschätzung der Strahlenexposition ermöglicht es dem OP-Personal, durch ein angepasstes Verhalten die eigene Strahlenbelastung während der Eingriffe zu reduzieren. Ziel unserer Arbeit war die Prüfung der Messgenauigkeit der EZD und die Bestimmung der Streustrahlung für einzelne Mitglieder des Operationsteams.In einem gefäßchirurgischen Operationssaal, ausgestattet mit einem C-Bogen, wurden Messungen der Strahlendosis des OP-Teams mithilfe eines EZD-Systems prospektiv durchgeführt. Zunächst wurde die Kalibrierung der EZD am OP-Tisch mit einem Wasserphantom überprüft. Danach wurden Messungen während gefäßchirurgischer Operationen durchgeführt.Die Messwerte der einzelnen EZD zeigten bei der Kalibrierung deutliche Abweichungen untereinander, deshalb wurde für jedes EZD ein Korrekturfaktor errechnet. Es wurden insgesamt 55 Eingriffe bei 53 Patienten untersucht. Die durchschnittliche Dosis für den EZD-Operateur bei der EVAR (endovascular aortic repair, n = 11) betrug 9 ± 9 µSv (Bereich 3,6 – 50 µSv) und bei der TEVAR (thoracic EVAR, n = 6) 35 ± 49 µSv (3,8 – 190,3 µSv). Bei den perkutanen transluminalen Angioplastien (PTA) der Beckengefäße und der unteren Extremitäten (n = 20) lag die durchschnittliche Dosis für den EZD-Operateur bei 7 ± 7 µSv (1,2 – 35 µSv) und bei den Angiografien der unteren Extremitäten (n = 12) bei 2 ± 3 µSv (0,2 – 15,9 µSv). Die Echtzeitdosimetrie lieferte Daten, die beim OP-Team mit zu einem veränderten Verhalten im Operationssaal führte.Da die bei der amtlichen Dosimetrie ermittelten Dosiswerte i. d. R. sehr klein sind, ist eine Optimierung des Verhaltens und damit des Strahlenschutzes mit diesen Dosiswerten nicht möglich. Die mit Strahlenschutzdosimetern ermittelten und in der neuen Strahlenschutzverordnung (StrlSchV) definierten Dosisrichtwerte sind dafür besser geeignet. Ein Vergleich der Messdaten, die mit den EZD ermittelt wurden, ist nur durch eine im Vorfeld vorgenommene Kalibrierung möglich.

Competency-based medical education is needed in order to meet the requirements of medical care currently and in the future. The basis of this are activity-based learning objectives that are merged in competency-based catalogues. A basis for a core curriculum of undergraduate medical training is the National Catalogue of Learning Objectives for Undergraduate Medical Education (NKLM). Already in 2013, for surgery, the competencies which medical students should have achieved after completing the practical year (PJ) in relation to surgical diseases were defined in the special part of the National Catalogue of Learning Objectives in Surgery (NKLC). In the now amended general part of the NKLC, interdisciplinary competencies were defined and consented from all surgical disciplines, that are relevant for all surgical disciplines and that all representatives from the different surgical disciplines should incorporate in their surgical training. The complete NKLC is now available for faculties, teachers and students for trial (available online: https://www.dgch.de/index.php?id=190L=528). The guiding principle for the entire development process was to make sure that students gain all competencies they need when starting to work as a medical doctor and therefor to increase patient safety.Um den Erfordernissen der medizinischen Versorgung aktuell und in Zukunft Rechnung zu tragen, wird die medizinische Aus- und Weiterbildung zunehmend kompetenzbasiert ausgerichtet. Grundlage bilden handlungsorientiert formulierte Lernziele, die in kompetenzorientierten Lernzielkatalogen zusammengeführt werden. Der Nationale Kompetenzbasierte Lernzielkatalog Medizin (NKLM) kann als fächerübergreifende Basis für ein Kerncurriculum herangezogen werden. Bereits 2013 sind für die chirurgischen Fachdisziplinen mit dem speziellen Teil des Nationalen Kompetenzbasierten Lernzielkataloges Chirurgie (NKLC) Handlungskompetenzen definiert worden, die die Studierenden nach Abschluss des Praktischen Jahres in Bezug auf konkrete Krankheitsbilder erreicht haben sollen. Mit dem nun ergänzten allgemeinen Teil des NKLC wurden disziplinübergreifend Kompetenzen definiert und von allen chirurgischen Fachdisziplinen konsentiert, die für sämtliche chirurgische Fachdisziplinen gleichermaßen Gültigkeit haben und von Vertreterinnen und Vertretern aller Fachdisziplinen in die Lehre einbezogen werden sollten. Der nun vollständige NKLC liegt den Fakultäten, Lehrenden und Lernenden zur Erprobung vor (verfügbar unter: https://www.dgch.de/index.php?id=190L=528). Leitgedanke für den gesamten Entwicklungsprozess waren das Erreichen der grundsätzlichen Weiterbildungsbefähigung und die Patientensicherheit beim Berufseinstieg.

The "Masterplan Medizinstudium 2020" from the German Federal Government should not be underestimated as only one among many announcement. Thus, the Surgical Working Group on Medical Education (CAL) of the German Association of Surgeons (DGCH) comments on the intended measures of the "Masterplan Medizinstudium 2020" and discusses the challenges, consequences and duties arising from the "Masterplan Medizinstudium 2020" for the representatives of the surgical societies and those engaged in surgical undergraduate training.Der „Masterplan Medizinstudium 2020“ der Bundesregierung darf in der Chirurgie keinesfalls als „beiläufiges Werk unter Vielen“ unterschätzt werden. Daher nimmt die chirurgische Arbeitsgemeinschaft Lehre (CAL) der Deutschen Gesellschaft für Chirurgie (DGCH) in ihrem Positionspapier zu den geplanten Maßnahmen im „Masterplan Medizinstudium 2020“ Stellung und diskutiert die Herausforderungen, Konsequenzen und Aufgaben, vor die der „Masterplan Medizinstudium 2020“ die Fachvertreter der chirurgischen Fachgesellschaften und die in der Lehre engagierten Chirurgen stellt.

Teaching training programs contribute to improving the quality of medical education. In a course of the Train-the-Trainer (TTT) concept of the Surgical Working Group for Teaching, teachers (TN) from different medical professions and career levels were taught together.Assessments of teaching activities in everyday clinical practice of residents (AÄ), senior staff (OÄ) and nurses (KP), their perception of teaching obstacles and requirements to improve teaching.Prior to the beginning of the course, biographical data, previous teaching experiences, teaching obstacles as well as their notions to improve teaching in the daily clinical routine were requested. Upon completion, the participants were asked to rate the course. The answers to the closed and open questions were evaluated quantitatively and qualitatively.From 2014 to 2017, six basic courses (TTT-A) were conducted at three locations. 97 participants participated in the surveys (AÄ n = 44, OÄ n = 19, KP n = 17). More than two-thirds declared previously acquired teaching knowledge. There were no significant differences between medical and nursing staff. While AÄ and KP primarily taught at the bedside, OÄ taught mainly in the context of lectures, electives and seminars. Only a small proportion of all occupational groups felt well prepared for teaching in everyday clinical practice. The main drawbacks were lack of time and staff, too many students per group and too little teaching knowledge. Nearly two-thirds of the AÄ found teaching in general as a strong or moderate burden, compared to about 50% of the OÄ and 60% KP. Aspirations for improvement of teaching included more precise characterisation of the learning objectives, greater appreciation of teaching as a whole, and regular measures to make teaching professional.Occupational group-related differences in everyday clinical practice and individual career progression, impact type, implementation and perception of the teaching activity. By focusing on learning objectives and essential teaching methods and examination formats relevant to teaching at the bedside, teacher training programs across professional groups can contribute to knowledge and expertise growth. Indications of a sustainable effect encourage the continuation and further development of the TTT concept.Didaktiktrainings tragen zur Verbesserung der Qualität der medizinischen Lehre bei. In einem Kurs des Train-the-Trainer-Konzepts (TTT-Konzepts) der Chirurgischen Arbeitsgemeinschaft Lehre (CAL) wurden dabei Lehrende (TN) verschiedener Professionen und Karrierestufen gemeinsam unterrichtet.Einschätzungen zur eigenen Lehrtätigkeit im klinischen Alltag durch verschiedene Gruppen, wie assistenzärztliches (AÄ), oberärztliches Personal (OÄ) und Pflegende (KP), deren Wahrnehmung von Erschwernissen und Artikulation von Wünschen zur Lehrverbesserung.Vor Kursbeginn wurden biografische Daten, didaktische Vorerfahrungen, Lehrhindernisse sowie Wünsche zur Lehrverbesserung erfragt. Nach Abschluss wurden die TN gebeten, den Kurs zu bewerten. Die Antworten zu den geschlossenen und offenen Fragen wurden quantitativ und qualitativ ausgewertet.Von 2014 bis 2017 wurden 6 Basiskurse (TTT-A) an 3 Standorten durchgeführt. 97 TN nahmen an den Befragungen teil (AÄ n = 44, OÄ n = 19, KP n = 17). Mehr als ⅔ verfügten bereits über didaktische Vorkenntnisse. Zwischen ärztlichen und pflegerischen Berufsgruppen fanden sich hierbei keine signifikanten Unterschiede. Während AÄ und KP primär am Krankenbett unterrichteten, lehrten OÄ überwiegend im Rahmen von Vorlesungen, Wahlfächern und Seminaren. Für die Lehre im klinischen Alltag fühlte sich nur ein geringer Anteil aus allen Berufsgruppen gut vorbereitet. Als Haupterschwernisse wurden Zeit- und Personalmangel, eine zu hohe Anzahl von Studierenden und zu geringe eigene didaktische Vorkenntnisse angegeben. Fast ⅔ der AÄ empfanden die studentische Lehre als starke oder moderate Belastung, gegenüber ca. 50% der OÄ und 60% KP. Als Wünsche zur Lehrverbesserung wurden differenziertere Vorgaben zu Inhalt und Aufbau der Lehrveranstaltungen, eine höhere Wertschätzung der Lehre insgesamt sowie die regelmäßige didaktische Qualifizierung der Lehrenden genannt.Berufsgruppenbedingte Unterschiede im klinischen Alltag und individueller Karrierefortschritt üben einen Einfluss auf Art, Umsetzung und Wahrnehmung der Lehrtätigkeit aus. Durch Fokussierung auf Lernziele und wesentliche für den Unterricht am Krankenbett relevante Lehr- und Prüfungsformate können Dozententrainingsprogramme berufsgruppenübergreifend zum Wissens- und Kompetenzzuwachs beitragen. Hinweise auf einen nachhaltigen Effekt ermutigen zur Fortsetzung und Weiterentwicklung des TTT-Konzepts.

Objectives The most effective first-line treatment between endovascular therapy and bypass surgery for patients with critical limb ischemia (CLI) is still not well defined. The primary aim of the interim analysis of CRITISCH (Registry of First-Line Treatments in Patients With Critical Limb Ischemia) was to compare both treatment options in a prospective confirmatory manner. Background Only 1 randomized controlled trial between endovascular therapy and bypass surgery has been published yet. Several retrospective studies showed comparable outcomes between the 2 treatment strategies, but in the majority of them, current endovascular technologies have not been included. Methods Between January 2013 and September 2014, 1,200 CLI patients (Rutherford 4 to 6) from 27 vascular centers were enrolled. The selection of the first-line treatment was left completely to the discretion of the responsible physician. The primary composite endpoint was amputation-free survival (AFS), that is, time to major amputation and/or death from any cause. A pre-specified interim analysis aimed at showing noninferiority of the endovascular therapy versus bypass surgery as to the hazard ratio (HR) of AFS (noninferiority bound = 1.33; interim α = 0.0058). Time-to-event analyses of major amputation, death, and the composite endpoint of reintervention and/or above-ankle amputation were also conducted. Results Endovascular therapy was applied to 642 (54%) and bypass surgery to 284 (24%) patients. Median follow-up time was 12 months in both groups. One-year AFS was 75% and 72%, respectively. The noninferiority of endovascular therapy versus bypass surgery for AFS was confirmed (HR: 0.91; upper bound of 1-sided (1 − 0.0058) confidence interval [CI]: 1.29; p = 0.003). An impact of the treatment strategy on time until death (HR: 1.14; 95% CI: 0.80 to 1.63; p = 0.453), major amputation (HR: 0.86; 95% CI:0.56 to 1.30; p = 0.463), and reintervention and/or above-ankle amputation (HR: 0.89; 95% CI: 0.70 to 1.14; p = 0.348) was not observed. Conclusions The interim analysis confirmed that when physicians are free to individualize therapy to CLI patients, the endovascular-first approach achieved a noninferior AFS rate compared with bypass surgery. (Registry of First-Line Treatments in Patients With Critical Limb Ischemia [CRITISCH]; NCT01877252)

Anhand eines Kurses zur Materialkunde in der Ausbildung zum EndoVascular Assistenten (EVA) werden bildungswissenschaftliche Methoden und Modelle zur Planung, Strukturierung und Durchfuhrung von Weiterbildungskursen dargestellt und eine Anleitung zur weiteren Anwendung in anderen gefasmedizinischen Fort- und Weiterbildungen diskutiert.

The two most important aneurysm types are cerebral aneurysms (CA) and abdominal aortic aneurysms (AAA), accounting together for over 80\% of all fatal aneurysm incidences. To minimise aneurysm related deaths, clinicians require various tools to accurately estimate its rupture risk. For both aneurysm types, the current state-of-the-art tools to evaluate rupture risk are identified and evaluated in terms of clinical applicability. We perform a comprehensive literature review, using the Web of Science database. Identified records (3127) are clustered by modelling approach and aneurysm location in a meta-analysis to quantify scientific relevance and to extract modelling patterns and further assessed according to PRISMA guidelines (179 full text screens). Beside general differences and similarities of CA and AAA, we identify and systematically evaluate four major modelling approaches on aneurysm rupture risk: finite element analysis and computational fluid dynamics as deterministic approaches and machine learning and assessment-tools and dimensionless parameters as stochastic approaches. The latter score highest in the evaluation for their potential as clinical applications for rupture prediction, due to readiness level and user friendliness. Deterministic approaches are less likely to be applied in a clinical environment because of their high model complexity. Because deterministic approaches consider underlying mechanism for aneurysm rupture, they have improved capability to account for unusual patient-specific characteristics, compared to stochastic approaches. We show that an increased interdisciplinary exchange between specialists can boost comprehension of this disease to design tools for a clinical environment. By combining deterministic and stochastic models, advantages of both approaches can improve accessibility for clinicians and prediction quality for rupture risk., Comment: 46 pages, 5 figures

Purpose: To examine the outcomes of all first-line strategies for the treatment of critical limb ischemia (CLI), identify factors that influenced the treatment choice, and determine the risk of amputation or death after each treatment. Methods: CRITISCH ( ClinicalTrials.gov identifier NCT01877252) is a multicenter, national, prospective registry evaluating all available treatment strategies applied in 1200 consecutive CLI patients in 27 vascular centers in Germany. The recruitment started in January 2013 and was completed in September 2014. Treatment options were endovascular revascularization (642, 53.5%), bypass surgery (284, 23.7%), femoral artery patchplasty (126, 10.5%) with or without concomitant peripheral intervention, conservative treatment (118, 9.8%), and primary major amputation (30, 2.5%). The primary endpoint of this study was amputation-free survival (AFS). The Society of Vascular Surgery’s suggested objective performance goal (OPG) for AFS (71%) was used as the effectiveness criterion. Multivariable regression methods were employed to identify variables that influenced the treatment selection and AFS after each treatment; results are presented as the hazard ratio (HR) and 95% confidence interval (CI). Results: The 12-month AFS estimates following endovascular therapy, bypass grafting, femoral patchplasty, and conservative treatment were 75%, 72%, 73%, and 72%, respectively. Factors influencing treatment choice were age, chronic kidney disease (CKD), diabetes, smoking, prior vascular procedures in the index leg, TransAtlantic Inter-Society Consensus II C/D lesions, and absence of runoff vessels. Cox regression analysis identified CKD (HR 2.07, 95% CI 1.26 to 3.41, p=0.004), the use of a prosthetic bypass conduit (HR 1.97, 95% CI 1.23 to 3.14, p=0.004), and previous vascular intervention in the index limb (HR 1.52, 95% CI 0.94 to 2.43, p=0.085) as independent risk factors for diminished AFS after bypass surgery. CKD (HR 1.47, 95% CI 1.09 to 1.99, p=0.012) and Rutherford category 6 (HR 1.81, 95% CI 1.30 to 2.52, p

An analysis was conducted of intermediate outcomes and possible influencing factors in patients with end-stage renal disease (ESRD) and critical limb ischemia after lower limb revascularization compared with patients with regular renal function (non-ESRD).Data collection was performed by inquiry of the German multicenter registry of First-Line Treatments in Patients with Critical Limb Ischemia (CRITISCH); 102 ESRD patients and 674 non-ESRD patients were included. Four different therapy modalities were analysed: bypass surgery, endovascular therapy (EVT), femoral artery endarterectomy, and no vascular intervention (conservative treatment or primary major amputation). Predefined end points were amputation-free survival (AFS), death, major amputation, and reintervention. Cox regression models were built to analyze independent risk factors for outcome parameters.ESRD patients showed inferior results at 2 years in the rate of AFS (ESRD, 35.4%; non-ESRD, 67.2%; P .001). Similarly, death rate (ESRD, 55.0%; non-ESRD, 20.7%; P .001) and major amputation rate (ESRD, 24.5%; non-ESRD, 15.8%; P = .029) were significantly elevated for ESRD patients. The choice of therapeutic approach in ESRD did not influence the incidence of the investigated end points (death or major amputation: EVT, 56.9% vs bypass, 76.9% [P = .225]; death: EVT, 46.2% vs bypass, 61.5% [P = .372]; amputation: EVT, 15.4% vs bypass, 15.4% [P = 1.000]; reintervention: EVT, 32.3% vs bypass, 15.4% [P = .324]). Cox regression analysis indicated that dialysis patients carry a twofold increased hazard of death or major amputation (hazard ratio, 2.27; 95% confidence interval, 1.67-3.10; P .001), and open surgical treatment (all patients combined) was associated with reduced risk of death compared with EVT (hazard ratio, 0.58; 95% confidence interval, 0.37-0.91; P = .017). Comorbidities were not found to have a noticeable impact on AFS, survival, reintervention, or major amputation.Two-year AFS, overall survival, and freedom from major amputation were decreased in ESRD patients compared with non-ESRD patients with critical limb ischemia. Cardiovascular comorbidities were without significant impact on outcome parameters, whereas choice of treatment modality within the ESRD group did not influence AFS. Decision-making in ESRD as to choice of therapeutic approach in dialysis patients should notably account for the individual's lesion characteristics and vascular disease; surgical revascularization and EVT may be used as complementary options.

Secondary prevention in patients with critical limb ischemia (CLI) is crucial for the reduction of cardiovascular morbidity and mortality. Nonetheless, current recommendations are extrapolated from other high-risk populations because of the lack of CLI-dedicated trials. The aim of this explorative study was to evaluate the association of statin therapy with the outcomes of CLI patients.The First-Line Treatments in Patients With Critical Limb Ischemia (CRITISCH) registry is a prospective multicenter registry analyzing the effectiveness of all available treatment strategies in 1200 CLI patients. For the purposes of this analysis, patients were divided into two groups based on statin administration. Treatment crossovers and nonadherent patients were excluded from analysis. The primary composite end point of this study was the amputation-free survival (AFS). Major adverse cardiovascular and cerebral events (MACCEs), time to death, and time to major amputation were also analyzed.Statin therapy was applied in 445 individuals (37%), 371 (31%) patients received no statins, and 384 subjects were excluded from analysis (treatment crossovers). Patients receiving statins were more likely to be younger (P .001) and to have a history of coronary heart disease (P .001) or previous intervention at index limb (P .001). Patients receiving statin therapy had a lower hazard regarding AFS (hazard ratio [HR], 0.45; 95% confidence interval [CI], 0.34-0.63; P .001) and death (HR, 0.40; 95% CI, 0.24-0.66; P .001) as well as lower odds of MACCE (odds ratio, 0.41; 95% CI, 0.23-0.69; P = .001). However, statin therapy was not associated with reduced amputation rates (HR, 1.02; 95% CI, 0.67-1.56; P = .922). Statin effect on AFS was consistent among diabetics (HR, 0.47; 95% CI, 0.31-0.70; P .001), patients with chronic kidney disease (HR, 0.53; 95% CI, 0.32-0.87; P = .012), and patients older than 75 years (HR, 0.40; 95% CI, 0.26-0.60; P .001). Statin administration was also associated with an improved AFS in patients with antiplatelet medication (HR, 0.64; 95% CI, 0.41-0.99; P = .049) and without antiplatelet medication (HR, 0.26; 95% CI, 0.12-0.57; P = .001) and after both endovascular therapy (HR, 0.51; 95% CI, 0.34-0.76; P = .001) and bypass revascularization (HR, 0.38; 95% CI, 0.21-0.68; P = .001).Statin therapy in CLI patients is associated with an increased AFS and lower rates of mortality and MACCEs without improving, however, the salvage rates of the affected limb.

Objective Analysis of in-hospital outcomes in patients treated for critical limb ischemia (CLI) and end-stage renal disease (ESRD) compared to CLI patients with normal renal function. Methods A subgroup analysis of the German CRITISCH registry, a prospective multicenter registry, assessing the first-line treatment strategies in CLI patients in 27 vascular centers in Germany was performed. The study cohort was divided into ESRD patients (n = 102) and patients with normal renal function (n = 674; glomerular filtration rate >60/mL/min/1.73 m 2 ). The following first-line treatment strategies were assessed: endovascular therapy (EVT), bypass surgery, patch plasty, and no vascular intervention (conservative treatment, primary amputation). Uni- and multivariate analyses were performed to identify differences between groups as to six end points: amputation or death (composite end point), amputation, death, hemodynamic failure, major adverse cardiac and cerebrovascular events, and reintervention. Results Differences between the ESRD and non-ESRD group were found regarding the applied first-line therapy ( P = .016): The first-line treatment strategies in ESRD patients were EVT in 64% (n = 65), bypass surgery in 13% (n = 13), patch plasty in 11% (n = 11), and no vascular intervention in 13% (n = 13). In non-ESRD patients, EVT was applied in 48% (n = 326), bypass surgery in 27% (n = 185), patch plasty in 13% (n = 86), and no vascular intervention in 11% (n = 77). For ESRD patients, a noticeably increased risk of the composite end point (odds ratio [OR], 2.62; 95% confidence interval [CI], 1.19-5.79; P = .017), amputation (OR, 3.14; 95% CI, 1.35-7.31; P = .008), and hemodynamic failure (OR, 2.19; 95% CI, 1.19-4.04; P = .012) was observed. Conclusions CLI patients on dialysis represent a challenging cohort prone to in-hospital death, amputation, and hemodynamic failure. Two-thirds of these high-risk patients are treated with EVT. Present data suggest that this modality is generally considered as the most favorable treatment option in this patient subgroup.

Critical limb ischemia (CLI) is growing in global prevalence and is associated with high rates of limb loss and mortality. However, a relevant gap of evidence about the most optimal treatment strategy still exists. The aim of this study of the prospective, multicenter First-Line Treatments in Patients With Critical Limb Ischemia (CRITISCH) registry was to assess the current practice of all first-line treatments strategies in CLI patients in German vascular centers.Between January 2013 and September 2014, five first-line treatment strategies-endovascular revascularization (ER), bypass surgery (BS), femoral/profundal artery patchplasty (FAP), conservative treatment, and primary amputation-were determined among CLI patients in 27 vascular tertiary centers. The main composite end point was major amputation or death, or both, during the hospital stay. Secondary outcomes were hemodynamic failure, major adverse cardiovascular and cerebral events, and reintervention. Univariate logistic models were additionally built to preselect possible risk factors for either event, which were then used as candidates for a multivariate logistic model.The study included 1200 consecutive patients. First-line treatment of choice was ER in 642 patients (53.4%), BS in 284 (23.7%), FAP in 126 (10.5%), conservative treatment in 118 (9.8%), and primary amputation in 30 (2.5%). The composite end point was met in 24 patients (4%) after ER, in 17 (6%) after BS, in 8 (6%) after FAP, and in 9 (8%) after conservative treatment (P = .172). The highest rate of in-hospital death was observed after primary amputation (10%) and of hemodynamic failure after conservative treatment (91%). Major adverse cardiovascular and cerebral events developed in 4% of patients after ER, in 5% after BS, in 6% after FAP, in 5% after conservative treatment, and in 13% after primary amputation. The reintervention rate was 8%, 14%, 6%, 5%, and 3% in each group, respectively. In the multivariate regression model, coronary artery disease (odds ratio [OR], 2.96; 95% confidence interval [CI], 1.42-6.17) and previous myocardial infarction (PMI)6 months (OR, 3.67, 95% CI, 1.51-8.88) were identified as risk factors for the composite end point. Risk factors for amputation were dialysis (OR, 3.31, 95% CI, 1.44-7.58) and PMI (OR, 3.26, 95% CI, 1.23-8.36) and for death, BS compared with ER (OR, 3.32; 95% CI, 1.10-10.0), renal insufficiency without dialysis (OR, 6.34; 95% CI, 1.71-23.5), and PMI (OR, 7.41; 95% CI, 2.11-26.0).The CRITISCH registry revealed ER as the most common first-line approach in CLI patients. Coronary artery disease and PMI6 months were independent risk factors for the composite end point. Special attention should be also paid to CLI patients with renal insufficiency, with or without dialysis, and those undergoing BS.

With conflicting results in the literature on the ability of photodynamic therapy (PDT) to inhibit intimal hyperplasia (IH), the present study systematically investigated the effects of drug and light dosimetry on the biologic responses in the artery wall. The rat common carotid artery was balloon-injured and pressurized with benzoporphyrin-derivative monoacid ring (BPD). Then, PDT was performed with an external laser at different fluences and the biologic responses of the artery wall were histologically examined at 24 h and at 2 weeks. Photodynamic therapy effects on injured arteries can be classified into four stages: low-dose PDT using 0.5 microgram/mL BPD at 50 J/cm2 (stage I) resulted in incomplete cell eradication and significant IH at 2 weeks. Irradiation with 100 J/cm2 at the same BPD concentration (stage II) completely eradicated the cells in the artery wall at 24 h but still led to IH at 2 weeks. However, 25 micrograms/mL BPD at 100 J/cm2 (stage III) resulted in total cell eradication at 24 h and inhibition of IH at 2 weeks. In contrast, high-dose PDT with 25 micrograms/mL BPD and 200 J/cm2 (stage IV) led to thrombus development and vascular occlusion at 24 h. These data, demonstrating the different stages of PDT effects on injured arteries, emphasize the critical importance of appropriate PDT dosimetry for the effective inhibition of IH.

Background Photodynamic therapy (PDT), the light activation of photosensitizer dyes for the production of free radicals, effectively inhibits experimental intimal hyperplasia with systemic administration of the photosensitizer. The local application of the photosensitizer directly into a vascular lesion to avoid systemic side effects and tightly control dose administration has theoretical appeal. The aim of this study was to quantify serum and arterial tissue uptake after site-specific photosensitizer delivery and, following PDT, determine its effectiveness at inhibiting intimal hyperplasia. Study Design/Materials and Methods The rat common carotid artery was balloon-injured, pressurized at 400 mm Hg for 2 minutes with the photosensitizer dye benzoporphyrin-derivative (BPD), and irradiated with 690 nm laser light at a fluence of 100 J/cm. Control animals were pressurized with saline only, or received no additional treatment than balloon-injury. Results Pressurization with BPD resulted in complete penetration of the intima and media and was associated with relatively high tissue, but almost no detectable serum BPD concentrations. No skin photosensitization or other systemic side effects were observed with photosensitizer administration. After 9 days, PDT-treated arteries displayed a significantly lower number of smooth muscle cells in the arterial wall than balloon-injured (P < 0.001) or saline-pressurized arteries (P < 0.0002), and no intimal hyperplasia. At 21 days, IH after PDT was significantly reduced as compared with balloon-injured (P < 0.0004), or saline-pressurized arteries (P 0.003) with no arterial dilatation. Conclusions Site-specific delivery of liposomal BPD followed by PDT represents a safe method to treat arteries, and may be effectively used in vivo to inhibit the development of intimal hyperplasia. Lasers Surg. Med. 23:263-273, 1998. © 1998 Wiley-Liss, Inc.

Objective: Procedurally related vascular injury results in a smooth muscle cell (SMC) proliferative response which is in part initiated by SMC release of mitogens, including basic fibroblast growth factor (bFGF). This injury-induced proliferative response is believed to be a key event in intimal hyperplasia development. Photodynamic therapy (PDT), a novel approach found to be effective in inhibiting experimental intimal hyperplasia, produces cytotoxic free radicals resulting in localized SMC eradication. However, this form of SMC injury does not induce an inflammatory or proliferative response in the vessel wall. This study investigated whether PDT-generated free radicals could inactivate cell-associated bFGF normally released with cell injury. Methods: PDT of bovine SMC was performed in vitro with the photosensitizer CASPc (5 μg/ml) and 675 nm laser light using three different fluences: 10, 50, and 100 J/cm2. After PDT, SMC viability was determined with the tetrazolium salt (MTT) assay and cell-associated bFGF was quantitated by ELISA. A SMC mitogenesis assay was utilized to detect cell-associated bFGF activity released with SMC injury. Results: In a dose-dependent manner, PDT-generated free radicals reduced cell-associated bFGF levels. After PDT with 100 J/cm2, cell-associated bFGF content was reduced by 88% ( P

Photodynamic therapy (PDT) has been demonstrated to inhibit experimental intimal hyperplasia and to lead to expedient reendothelialization but negligible repopulation of the vessel media. The mechanism that underlies the differential ingrowth of cells into PDT-treated vessel segments is not understood. Because the extracellular matrix (ECM) is known to modulate specific cell functions, this study was designed to determine whether PDT of isolated ECM affects the function of endothelial cells (ECs) and smooth muscle cells (SMCs).PDT of bovine aortic EC-ECM was performed with chloroaluminum sulfonated phthalocyanine and 675-nm laser light. Control specimens included untreated ECM, ECM-free plates, and ECM exposed to either light or photosensitizer only. Cell function was characterized by attachment, proliferation, and migration of ECs or SMCs that were plated onto identically treated matrixes.SMC attachment (86% +/- 0.4% vs 95% +/- 0.4%), proliferation (46% +/- 0.5% vs 100% +/- 1.4%), and migration (40% +/- 1.0% vs 100% +/- 0.9%) were significantly inhibited after PDT of ECM when compared with untreated ECM (all p0.001). In contrast, PDT of ECM significantly enhanced EC proliferation (129% +/- 6.2% vs 100% +/- 6.2%; p0.03) and migration (118% +/- 2% vs 100% +/- 0.8; p0.01), but did not affect attachment.This report establishes PDT-induced changes in the ECM with a result of inhibition of SMCs and stimulation of EC functions. It provides insight into how PDT-treated arteries can develop favorable EC repopulation without SMC-derived intimal hyperplasia. These findings may help provide a better understanding of the interactions between cells and their immediate environment in vascular remodeling.

Background Biological vascular allografts have proved unsatisfactory because of thrombosis, occlusion, and aneurysmal degeneration during chronic rejection. Photodynamic therapy (PDT), a technique that leads to the production of cytotoxic free radicals, was investigated as a novel method to prepare arterial allografts. Methods and Results Shortly after impregnation with the photosensitizer drug chloroaluminum sulfonated phthalocyanine, infrarenal aortas of ACI rats were PDT-treated and orthotopically grafted in Lewis rats (PDT). The transplanted grafts were sequentially analyzed at 2, 4, and 8 weeks by morphometry, immunohistochemistry, and scanning electron microscopy. Of 25 untreated allografts, 4 (16%) developed aneurysms compared with 0 of 33 in PDT or untreated isografts (ISO, P P P Conclusions Our findings suggest that local PDT treatment of arterial allografts inhibits inflammatory infiltration, aneurysmal dilatation, and development of intimal hyperplasia and may be used to develop vascular bioprostheses for use in humans.

Purpose: There is no clinically useful therapy for the suppression of vein bypass graft intimal hyperplasia (IH). Photodynamic therapy (PDT), a technique that uses light to activate otherwise biologically inert photosensitizers to produce cytotoxic effects, has been demonstrated to successfully inhibit experimental IH in balloon-injured arteries. The purpose of this study was to investigate the efficacy of PDT as a method to reduce vein graft IH.Methods: Reversed external jugular vein bypass grafts of the common carotid artery were performed in 28 male Sprague-Dawley rats. The animals received either chloroaluminum sulfonated phthalocyanine (2.5 mg/kg intravenously) 24 hours before the ex vivo irradiation of the vein grafts (VG) with 100 joule/cm2 at 675 nm (PDT VG) or saline solution as control (CON VG). Preharvest bromodeoxyuridine was administered to label proliferating cells. All vein grafts were perfusion fixed within 96 hours for a pilot study or at 2 and 4 weeks for the main study. Histology, immunohistochemistry, and morphometric analysis were performed.Results: There was no acute thrombus formation in the hypocellular PDT VG with occasional platelets but no leukocytes adherent to the luminal surface. Intimal areas of the PDT VG were 18% at 2 weeks and 53% at 4 weeks of the CON VGs (p < 0.05). Medial areas and percent of stenoses were also significantly less in PDT than in CON VG. However, intimal hyperplasia noted in the longitudinal sections within 2 mm of the anastomoses did not demonstrate a difference between PDT and CON VG. Intimal hyperplasia of both PDT and CON VG consisted of smooth muscle cells, verified by immunohistochemistry. Bromodeoxyuridine-labeled cells were more abundant in 2-week than in 4-week specimens, were found most frequently in the intimal areas of the CON VG body, and were equivalent in the anastomoses of PDT VG and CON VG.Conclusions: These data suggest that PDT of vein grafts suppresses the development of IH in the body of the vein graft but does not affect IH adjacent to the anastomoses. The artery may be the source of proliferating smooth muscle cells that contribute to the anastomotic vein graft IH. (J VASC SURG 1995;21:882-90.)

Objective— The role of fluid shear stress (FSS) in collateral vessel growth remains disputed and prospective in vivo experiments to test its morphogenic power are rare. Therefore, we studied the influence of FSS on arteriogenesis in a new model with extremely high levels of collateral flow and FSS in pig and rabbit hind limbs. Methods and Results— A side-to-side anastomosis was created between the distal stump of one of the bilaterally occluded femoral arteries with the accompanying vein. This clamps the collateral reentry pressure at venous levels and increases collateral flow, which is directed to a large part into the venous system. This decreases circumferential wall stress and markedly increases FSS. One week after anastomosis, angiographic number and size of collaterals were significantly increased. Maximal collateral flow exceeded by 2.3-fold that obtained in the ligature-only hind limb. Capillary density increased in lower leg muscles. Immunohistochemistry revealed augmented proliferative activity of endothelial and smooth muscle cells. Intercellular adhesion molecule-1 and vascular cell adhesion molecule (VCAM)-1 were upregulated, and monocyte invasion was markedly increased. In 2-dimensional gels, actin-regulating cofilin1 and cofilin2, destrin, and transgelin2 showed the highest degree of differential regulation. Conclusions— High levels of FSS cause a strong arteriogenic response, reinstate cellular proliferation, stimulate cytoskeletal rearrangement, and normalize maximal conductance. FSS is the initiating molding force in arteriogenesis.

Fur die parenterale antithrombotische Behandlung von Patienten mit heparininduzierter Thrombozytopenie Typ II (HIT II) steht der direkte Thrombininhibitor Argatroban zur Verfugung. Erfahrungen hierzu wurden auf einem Workshop anhand von Fallbeispielen und einer Expertenumfrage ausgetauscht. Ziel war es, die Indikationen und Anwendungsmodalitaten von Argatroban in der Gefaschirurgie zu definieren. Die im Workshop empfohlene korpergewichtsbezogene therapeutische Dosierung betragt 0,5–2 μg/kg/min i.v. Die Therapie kann mittels aPTT uberwacht werden, wobei eine 1,5- bis 3-fache Verlangerung der aPTT angestrebt wird. Eine Dosisreduktion ist bei einer eingeschrankten Leberfunktion erforderlich. Soll erst intraoperativ antikoaguliert werden, so ist die Gabe eines Bolus unmittelbar vor Abklemmen der Gefase (z. B. Abklemmen der A. carotis oder der Aorta) moglich (Bolus von 5–15 mg, je nach Korpergewicht; Praferenz 10 mg). Die Therapie kann dann mit einer Infusion von 0,5 bis 2 µg/kg/min fortgesetzt werden, wobei die Tagesdosis zu beachten ist. (Fur einen 70-kg-Patienten sind dies etwa 50 bis 200 mg). Bei der Anwendung von Argatroban bestehen Unsicherheiten. Die hier prasentierten Dosierungsvorschlage haben eine erhebliche Breite, abhangig von der kardialen Situation des Patienten, seiner Leberfunktion und davon, ob der Patient einer Intensivtherapie bedarf. Die Dosierungsvorschlage sollten nun weiter uberpruft werden. Die Forschungskommission der Deutschen Gesellschaft fur Gefaschirurgie schlagt deshalb vor, HIT-II-Patienten in Zukunft in einem Register zu erfassen. Bei der seltenen Inzidenz der Erkrankung sind alle chirurgischen Intensivstationen aufgerufen, sich daran zu beteiligen.

Purpose: Photodynamic therapy (PDT), the light activation of photosensitizers to produce free radicals, is known to inhibit experimental intimal hyperplasia (IH). However, its clinical application has been limited by the lack of a suitable approach and a clinically appropriate photosensitizer. The aim of this study was to determine the effectiveness of a clinical approach for PDT, while testing its ability to favorably modulate the vascular wound healing response. Methods: Rat carotid arteries were balloon-injured (BI), and for PDT, the arteries were irradiated with thermoneutral laser light (λ = 660 nm, 100 J/cm2) after the photosensitizer methylene blue (MB) was delivered locally. Control rats included BI alone and MB after BI alone. Arteries were analyzed after 2 weeks with morphometric evaluation (n = 6) and in situ hybridization for versican and procollagen type I gene expression (digitized image pixel analyses, n = 3). Results: No IH developed in PDT-treated arteries (0 ± 0 mm2; compared with BI, 0.192 ± 0.006 mm2; P

Primary malignant melanoma of the esophagus is an extremely rare tumor. In the absence of prospectively sampled data in the literature, the following case report and review of the literature indicate that surgical resection of the primary tumor and solitary metastases provides the longest survival times and, to date, is the treatment of choice.

Autologe Arterien- und Venentransplantate gehoren zum unverzichtbaren Instrumentarium des Herz- und Gefaschirurgen. Da gegenwartig keine zufriedenstellenden synthetischen Prothesen fur kleinkalibrige Gefase (Durchmesser < 6 mm) existieren und autologe Arterien und Venen nur in begrenztem Umfang zur Verfugung stehen, besteht seit kurzem ein wiedererwachtes Interesse an der Transplantation allogener Gefase [1]. Biologische Gefasprothesen besitzen neben uberlegener biomechanischer Eigenschaften, eine vergleichsweise hohe Infektresistenz und gestatten eine schnellere und vollstandigere Reendothelialisierung im Vergleich zu synthetischen Ersatzmaterialien. Eine breite Anwendung biologischer Gefasprothesen wurde bisher jedoch durch die erhohte Inzidenz von Aneurysmabildung aufgrund einer chronischen Abstosungsreaktion verhindert [2]. Die Immunisierung des Empfangers geht dabei in erster Linie von glatten Muskelzellen aus der Media des Transplantates aus [3]. Fur die Funktion als Blutleiter sind diese Zellen jedoch nur von untergeordneter Bedeutung.

The long-term benefit of coronary or peripheral vascular interventions is limited by restenosis, due to intimal hyperplasia (IH). Photodynamic therapy (PDT) with systematic delivery of the photosensitizing drug, performed either at the time or shortly after vascular injury, has been demonstrated to effectively inhibit the development of experimental IH. However, in order to deliver large quantities of the photosensitizer, but avoid systematic photosensitization, local delivery of the drug appears to be an advantageous option. An experimental model was therefore developed to deliver benzporphyrin derivative (BPD-MA) directly into isolated segments of balloon-injured rat common carotid arteries, and to study the uptake in serum and arterial tissue by means of spectrofluorometry. Furthermore, early effects of local versus systematic drug delivery and subsequent PDT treatment, were investigated with light microscopy and morphometric analysis. Local delivery of BPD lead to effective drug concentrations in the artery with complete depletion of endothelial and smooth muscle cells, already 24 h after PDT. The media appeared compacted and acellular. No thrombosis or occlusion were observed. Serum concentrations of BPD, after local delivery, were at the detection threshold, whereas systematic application resulted in significantly higher serum but equivalent tissue drug concentrations. In conclusion, these data demonstrate that local delivery of BPD results in tissue concentrations, appropriate to perform an efficient vascular PDT treatment of the arterial wall.

Femoral artery puncture is the most common method of vascular access for all kinds of endovascular procedures. The possible complications of the femoral artery puncture are diverse and partially critical. Local complications may include hematoma, pseudoaneurysm, formation of arteriovenous fistula